A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections, Pneumococcal Infections

In brief

To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination. Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.

Key facts

Study ID

NCT00000829

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Expected to finish

1999-10-01

Last updated by the study team

2021-10-28

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Antipyretics for rectal temperature >= 100.4 F.
• Antiretroviral therapy.
• Patients must have:
• HIV positivity.
• Birth weight at least 1800 g (3.75 lb).
• Consent and compliance of parent or guardian.
• NOTE:
• Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Enrollment in HIV vaccine trials.
• Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures.
• Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia.
• Hypogammaglobulinemia.
• Concurrent Medication:
• Excluded:
• Prophylactic antipyretics.
• Patients with the following prior conditions are excluded:
• Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry.
• Prior Medication:
• Excluded:
• Any prior pneumococcal vaccine.
• Measles vaccine within 1 month prior to study vaccination.
• Any other routine vaccine within 1 week prior to study vaccination.
• Any immunosuppressant agent, including prednisone, for more than 6 weeks.
• Prior Treatment:
• Excluded:
• Blood products within 56 days prior to study vaccination.

Where it is running

• Usc La Nichd Crs — Los Angeles, California, United States
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• San Francisco Gen. Hosp. — San Francisco, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Atlanta, Georgia, United States
• Cook County Hosp. — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States
• UMDNJ - Robert Wood Johnson — New Brunswick, New Jersey, United States
• NJ Med. School CRS — Newark, New Jersey, United States
• North Shore-Long Island Jewish Health System, Dept. of Peds. — Great Neck, New York, United States
• NYU Med. Ctr., Dept. of Medicine — New York, New York, United States
• Columbia IMPAACT CRS — New York, New York, United States
• Incarnation Children's Ctr. — New York, New York, United States
• Harlem Hosp. Ctr. NY NICHD CRS — New York, New York, United States
• Strong Memorial Hospital Rochester NY NICHD CRS — Rochester, New York, United States
• SUNY Stony Brook NICHD CRS — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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